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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2006-003560-62-FR |
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Date of registration:
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06/03/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects with Schizophrenia
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Scientific title:
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A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects with Schizophrenia |
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Date of first enrolment:
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14/05/2007 |
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Target sample size:
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700 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003560-62 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Bulgaria
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Czech Republic
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Estonia
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France
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Germany
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Hungary
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Lithuania
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Men or women, aged at least 18 years old
- Meet diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening
- A total PANSS score between 60 and 120, inclusive, at screening and baseline
- Body mass index (BMI) of > (or equal) 17.0 kg/m²
- Female subjects must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study. Effective methods of birth control include contraceptive pills, coil, depot injection of gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patches. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Unable to provide their own consent or involuntarily committed to psychiatric hospitalization
- A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
- A decrease of > (or equal) to 25% in the total PANSS score between screening and baseline as calculated using the table provided by the sponsor
- A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
- Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI > 40 kg/m²) or other systemic disease
- History or evidence of clinically significant hepatic disease [including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal] at screening
- Significant risk of suicidal or violent behavior, as clinically assessed by the investigator
- Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
- Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening or participated in 2 or more clinical studies in the past year
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Schizophrenia
MedDRA version: 8.1
Level: LLT
Classification code 10039626
Term: Schizophrenia
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Intervention(s)
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Trade Name: INVEGA
Product Name: Paliperidone OROS 6mg extended release (ER) system
Product Code: F040
Pharmaceutical Form: Tablet
INN or Proposed INN: paliperidone
Current Sponsor code: R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Product Name: Paliperidone Palmitate 50 mg
Product Code: F013
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Paliperidone Palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Product Name: Risperdal 1 mg Tablets
Product Code: F005
Pharmaceutical Form: Tablet
INN or Proposed INN: Risperidone
Current Sponsor code: R064766
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: RISPERDALCONSTA
Product Name: RISPERDALCONSTA
Product Code: F109
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Risperidone
Current Sponsor code: R064766
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Product Name: Paliperidone Palmitate 100 mg
Product Code: F013
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Paliperidone Palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Product Name: Paliper
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to demonstrate that paliperidone palmitate is not less effective than risperidone long-acting i.m. injection (LAI) (RISPERDALCONSTA). The safety and tolerability of paliperidone palmitate in the treatment of schizophrenia will also be assessed.
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Secondary Objective: - Assessment of the global improvement in severity of illness associated with the use of paliperidone palmitate compared with risperidone LAI.
- Explore the effects to personal and social functioning associated with the use of paliperidone palmitate compared with risperidone LAI.
- Explore the effects of paliperidone palmitate compared with risperidone LAI in improvement of sleep quality and reduction of daytime sleepiness.
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Primary end point(s): The primary endpoint is the charge in the total of the PANSS from baseline to the last postrandomization assessement in the double-blind treatment period. The criterion for evaluation will be the demonstration that the primary endpoint is no worse in paliperidone palmitate treated subjects than in risperidone LAI treated subjects by a predefined noninferiority margin of 5 points in the change in the total PANSS score.
Secondary endpoints will include the Clinical Global Improvement-Severity (CGI-S), Personal and Social Performance Scale (PSP), Schedule for Deficit Syndrome (SDS), Pittsburgh Sleep Quality Index (PSQI), Sleep Visual Analog Scale (Sleep VAS), PANSS subscales, and responder rate.
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Secondary ID(s)
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R092670-PSY-3006
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2006-003560-62-HU
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 06/03/2006
Contact:
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